Relapsing Remitting Multiple SclerosisPhase 4SUPERNEXTNCT04225312
Personalized Extended Interval Dosing of Natalizumab in Relapsing Remitting Multiple Sclerosis
A Phase 4 study testing Personalized extended interval dosing of natalizumab and Standard interval dosing in people with Relapsing Remitting Multiple Sclerosis, run by Amsterdam UMC, location VUmc at 24 sites in Netherlands.
Trial summary
Rationale: Natalizumab is an effective drug in the treatment for relapsing remitting multiple sclerosis (RRMS) and is approved by de FDA/EMA in a treatment regimen of 4-weekly 300mg natalizumab infusions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Personalized extended interval dosing of natalizumab and Standard interval dosing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 24 sitesNetherlands
- Study dates
- 3 Feb 2020to 1 Mar 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of relapsing remitting multiple sclerosis according to the 2017 criteria
- 6 or more consecutive natalizumab infusions
- 18 years or older
- Agreed to participate (written informed consent)
Who cannot join
- High titer natalizumab (>100 arbitrary units (AU)/ml) antibodies
- Contraindication for frequent magnetic resonance imaging (MRI) (ie, pacemaker or other contraindicated implanted metal devices, or have claustrophobia that cannot be medically managed)
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Netherlands24 sites
Jeroen Bosch Hospital
's-Hertogenbosch
Ziekenhuisgroep Twente hospital
Almelo
Flevoziekenhuis
Almere Stad
Amsterdam UMC, location VUmc
Amsterdam
OLVG
Amsterdam
Rijnstate Hospital
Arnhem
Wilhelmina hospital Assen
Assen
Amphia Hospital
Breda
Reinier de Graaf hospital
Delft
Slingeland Hospital
Doetinchem
Ommelander Hospital Groningen
Groningen
University Medical Center Groningen
Groningen
Spaarne gasthuis hospital
Haarlem
Sint-Jansdal Hospital
Harderwijk
Medisch Centrum Leeuwarden
Leeuwarden
Alrijne Hospital
Leiden
Maasstad hospital
Maastricht
Canisius Wilhelmina Hospital
Nijmegen
Erasmus Medical Center
Rotterdam
Haaglanden Medical Center
The Hague
Elizabeth tweesteden Hospital
Tilburg
Diakonessenhuis
Utrecht
St. Antonius Hospital
Utrecht
Isala
Zwolle
About this study
Rationale: Natalizumab is an effective drug in the treatment for relapsing remitting multiple sclerosis (RRMS) and is approved by de FDA/EMA in a treatment regimen of 4-weekly 300mg natalizumab infusions. Natalizumab trough concentrations after a 4-weekly interval are high in the large majority of patients which implies a relative overdose in most patients. A recent randomized controlled trial (RCT) suggests natalizumab maintains a high level of effi-cacy in stable patients with RRMS switching to a 6 week interval. Our study group demon-strated that efficacy of natalizumab is maintained when the infusion interval is extended based on natalizumab trough concentrations (personalized extended interval dosing). This leads to fewer hospital visits, a decrease of healthcare costs and decrease of risk of compli-cations of natalizumab treatment.
Objective: Our objective is to test feasibility and validate safety of personalized extended interval dosing of natalizumab starting from 6 weeks in a large real-life cohort across the Netherlands.
Read more
Study design: Prospective national phase IV natalizumab cohort study.
Study population: All patients, aged 18 years or older, who are currently treated with natalizumab in the Netherlands for RRMS, with a minimum of 6 consecutive infusions.
Intervention: All patients currently included in the NEXT-MS trial will receive an adjusted personalized extended interval dosing treatment regimen of natalizumab based on natalizumab concentrations starting from an infusion interval of 6 weeks.
Main study parameters/endpoints: Our main study endpoint is the safety (defined by radiological disease activity) of personalized natalizumab dosing in a large real-life cohort across the Netherlands. Data will be collected regarding disease activity and disability progression. A cost analysis will be performed to show the extent of cost reduction. Patients will be annually followed to assess the influence of personalized dosing on JC virus conversion, JC virus index, incidence of progressive multifocal leukoencephalopathy, treatment satisfaction and quality of life. The influence of personalized dosing on pharmacokinetics will be monitored.
Read the detailed description
This a national open label phase IV natalizumab cohort study. Our aim is that the large majority of natalizumab treated RRMS patients who are currently treated with PEID in The Netherlands will continue in this study with a treatment interval ≥6 weeks. We will continue the NEXT-MS study with 24 participating centers. The study duration is two years. This study will contain the PEID group, a control group and a historic control group. Participants will decide in which group they will participate as this is an open label, non-randomized study. We have chosen this design as we expect the large majority of patients wanting a personalized natalizumab treatment for the following reasons. Others and our own study group have studied personalized and extended dosing of natalizumab treatment, all indicating that this is a safe approach. Data from the NOVA trial support this approach. As we see a drastic reduction of PML risk with extended interval dosing there is a growing trend internationally to personalized/extended interval dosing. Furthermore, there is an increasing wish in patients and physicians for personalized treatment to increase patient convenience and lowering costs of expensive medication and healthcare.
Based on recent data from the NOVA-trial and data from our preliminary analyses, all patients in the PEID group will continue with personalized dosing with an interval ≥6 weeks. The PEID study group will receive a personalized treatment with the aim of a natalizumab trough concentration of 5μg/ml.
If patients do not desire a personalized treatment, they will be asked informed consent for the use of their patient data and for the questionnaires as the control group. As this introduces a bias, the PEID group will be compared to a historical cohort of Amsterdam MS Center.
Furthermore, the patients of the control group will be asked to donate blood once for measuring of natalizumab trough concentration.
As of April 2021, the European Commission has granted marketing authorization for SC in-jection of natalizumab. As pharmacokinetics and pharmacodynamics between SC and IV ad-ministration resulted in comparable trough natalizumab serum concentration and a4-integrin receptor saturation, patients who desire a switch from IV administration to SC administration will have the opportunity to continue the study in the same study group.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- Personalized extended interval dosing of natalizumab, Standard interval dosing
- Keywords
- Natalizumab, Extended interval dosing
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized extended interval dosing of natalizumabDrug
Also called EID
Personalized extended interval dosing of natalizumab with a schedule from every 6 weeks, which will be further extended if the trough level exceeds 10 ug/ml.
Standard interval dosingDrug
Also called SID
Standard interval dosing in control group and historic group
| Study group | Role | What they receive |
|---|---|---|
| Personalized extended interval dosing | Experimental | Patients will be receiving a personalized dosing schedule from 6 weeks, which will be further extended if the trough level exceeds 10 ug/ml. Receives: Drug: Personalized extended interval dosing of natalizumab |
| Standard interval dosing | Other | Patients who prefer to stay on standard interval dosing. Receives: Drug: Standard interval dosing |
| Historic cohort | Other | Historic cohort of natalizumab treated patients on standard interval dosing. Receives: Drug: Standard interval dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of T2 lesions on brain MRI
Assessing new/enlarging T2 lesions on brain MRI
Measured: Baseline, year 1, year 2
Secondary outcomes (13)
Annualized relapse rate
Clinical relapses during personalized extended interval dosing
Measured: Baseline, year 1, year 2
Disability progression during follow-up
Disability progression measured on the Expanded Disability Status Scale (EDSS); running form 0 (no disability) to 10 (death)
Measured: Baseline, year 1, year 2
Cost analysis
Cost-utility analysis using EuroQol 5D (EQ-5D) and the Work Productivity and Activtiy Impairment Questionnaire (WPAI).
Measured: Baseline, year 1, year 2
JC virus conversion
Annual conversion rate of the John Cunningham Virus (JCV)
Measured: 6 monthly JCV measurement for two years
Course JC virus index
Course of John Cunningham Virus (JCV) index in JCV positive patients
Measured: 6 monthly JCV measurement for two years
Natalizumab wearing-off effect
Occurrence of the natalizumab wearing-off effect
Measured: Baseline, year 1, year 2
Stability of natalizumab trough concentration
Long-term stability of natalizumab trough concentration in personalized interval dosing
Measured: 6 monthly natalizumab trough concentrations for two years
Patient preference
Percentage of patients preferring personalized treatment over standard treatment and percentage staying on personalized treatment
Measured: Baseline
Quality of life: MSIS-29
Quality of life on the Multiple Sclerosis Impact Scale (MSIS-29)
Measured: Baseline, year 1, year 2
Satisfaction of treatment: TSQM
Satisfaction of treatment on the Treatment Satisfaction Questionnaire of Medication (TSQM)
Measured: Baseline, year 1, year 2
Progressive multifocal leukoencephalopathy
Incidence of progressive multifocal leukoencephalopathy
Measured: Trough study completion, an average of 2 years
Brain atrophy
Percentage of patients preferring personalized treatment over standard treatment and percentage staying on personalized treatment
Measured: Baseline, year 1, year 2
Serum neurofilament light levels
Difference in serum neurofilament light levels with personalized interval dosing
Measured: Trough study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start3 Feb 2020
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective national phase IV natalizumab cohort study
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting MS Research, Innovatiefonds Zorgverzekeraars, Stichting Treatmeds
- Responsible party
- Principal investigator, Zoé van Kempen, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225312
- Sponsor's protocol ID
- NL70503.029.19
- Acronym
- SUPERNEXT
- Status last verified
- Apr 2023
- First submitted
- 3 Jan 2020
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Foley JF, Defer G, Ryerson LZ, Cohen JA, Arnold DL, Butzkueven H, Cutter G, Giovannoni G, Killestein J, Wiendl H, Smirnakis K, Xiao S, Kong G, Kuhelj R, Campbell N; NOVA study investigators. Comparison of switching to 6-week dosing of natalizumab versus continuing with 4-week dosing in patients with relapsing-remitting multiple sclerosis (NOVA): a randomised, controlled, open-label, phase 3b trial. Lancet Neurol. 2022 Jul;21(7):608-619. doi: 10.1016/S1474-4422(22)00143-0. Epub 2022 Apr 25.
PubMed 35483387Toorop AA, van Lierop ZY, Gelissen LM, Hoitsma E, Zeinstra EM, van Rooij LC, van Munster CE, Vennegoor A, Mostert JP, Wokke BH, Kalkers NF, Hoogervorst EL, van Eijk JJ, Roosendaal CM, Kragt JJ, Eurelings M, van Genugten J, Nielsen J, Sinnige L, Kloosterziel ME, Arnoldus EP, van Dijk GW, Bouvy WH, Wessels MH, Boonkamp L, Strijbis EM, van Oosten BW, De Jong BA, Lissenberg-Witte BI, Barkhof F, Moraal B, Teunissen CE, Rispens T, Uitdehaag BM, Killestein J, van Kempen ZL. Prospective trial of natalizumab personalised extended interval dosing by therapeutic drug monitoring in relapsing-remitting multiple sclerosis (NEXT-MS). J Neurol Neurosurg Psychiatry. 2024 Apr 12;95(5):392-400. doi: 10.1136/jnnp-2023-332119.
PubMed 37963723
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Extended Interval Dosing of Natalizumab in Relapsing Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04225312
- Acronym / sponsor ID
- SUPERNEXT / NL70503.029.19
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Natalizumab, Extended interval dosing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Stichting MS Research, Innovatiefonds Zorgverzekeraars, Stichting Treatmeds
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: Natalizumab is an effective drug in the treatment for relapsing remitting multiple sclerosis (RRMS) and is approved by de FDA/EMA in a treatment regimen of 4-weekly 300mg natalizumab infusions. Natalizumab trough concentrations after a 4-weekly interval are high in the large majority of patients which implies a relative overdose in most patients. A recent randomized controlled trial (RCT) suggests natalizumab maintains a high level of effi-cacy in stable patients with RRMS switching to a 6 week interval. Our study group demon-strated that efficacy of natalizumab is maintained when the infusion interval is extended based on natalizumab trough concentrations (personalized extended interval dosing). This leads to fewer hospital visits, a decrease of healthcare costs and decrease of risk of compli-cations of natalizumab treatment.
Objective: Our objective is to test feasibility and validate safety of personalized extended interval dosing of natalizumab starting from 6 weeks in a large real-life cohort across the Netherlands.
Study design: Prospective national phase IV natalizumab cohort study.
Study population: All patients, aged 18 years or older, who are currently treated with natalizumab in the Netherlands for RRMS, with a minimum of 6 consecutive infusions.
Intervention: All patients currently included in the NEXT-MS trial will receive an adjusted personalized extended interval dosing treatment regimen of natalizumab based on natalizumab concentrations starting from an infusion interval of 6 weeks.
Main study parameters/endpoints: Our main study endpoint is the safety (defined by radiological disease activity) of personalized natalizumab dosing in a large real-life cohort across the Netherlands. Data will be collected regarding disease activity and disability progression. A cost analysis will be performed to show the extent of cost reduction. Patients will be annually followed to assess the influence of personalized dosing on JC virus conversion, JC virus index, incidence of progressive multifocal leukoencephalopathy, treatment satisfaction and quality of life. The influence of personalized dosing on pharmacokinetics will be monitored.
Detailed description
This a national open label phase IV natalizumab cohort study. Our aim is that the large majority of natalizumab treated RRMS patients who are currently treated with PEID in The Netherlands will continue in this study with a treatment interval ≥6 weeks. We will continue the NEXT-MS study with 24 participating centers. The study duration is two years. This study will contain the PEID group, a control group and a historic control group. Participants will decide in which group they will participate as this is an open label, non-randomized study. We have chosen this design as we expect the large majority of patients wanting a personalized natalizumab treatment for the following reasons. Others and our own study group have studied personalized and extended dosing of natalizumab treatment, all indicating that this is a safe approach. Data from the NOVA trial support this approach. As we see a drastic reduction of PML risk with extended interval dosing there is a growing trend internationally to personalized/extended interval dosing. Furthermore, there is an increasing wish in patients and physicians for personalized treatment to increase patient convenience and lowering costs of expensive medication and healthcare.
Based on recent data from the NOVA-trial and data from our preliminary analyses, all patients in the PEID group will continue with personalized dosing with an interval ≥6 weeks. The PEID study group will receive a personalized treatment with the aim of a natalizumab trough concentration of 5μg/ml.
If patients do not desire a personalized treatment, they will be asked informed consent for the use of their patient data and for the questionnaires as the control group. As this introduces a bias, the PEID group will be compared to a historical cohort of Amsterdam MS Center.
Furthermore, the patients of the control group will be asked to donate blood once for measuring of natalizumab trough concentration.
As of April 2021, the European Commission has granted marketing authorization for SC in-jection of natalizumab. As pharmacokinetics and pharmacodynamics between SC and IV ad-ministration resulted in comparable trough natalizumab serum concentration and a4-integrin receptor saturation, patients who desire a switch from IV administration to SC administration will have the opportunity to continue the study in the same study group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective national phase IV natalizumab cohort study
| Arm | Type | Receives |
|---|---|---|
| Personalized extended interval dosing | Experimental | Drug: Personalized extended interval dosing of natalizumabPatients will be receiving a personalized dosing schedule from 6 weeks, which will be further extended if the trough level exceeds 10 ug/ml. |
| Standard interval dosing | Other | Drug: Standard interval dosingPatients who prefer to stay on standard interval dosing. |
| Historic cohort | Other | Drug: Standard interval dosingHistoric cohort of natalizumab treated patients on standard interval dosing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of relapsing remitting multiple sclerosis according to the 2017 criteria
- 6 or more consecutive natalizumab infusions
- 18 years or older
- Agreed to participate (written informed consent)
Key exclusion criteria (2 listed)
- High titer natalizumab (>100 arbitrary units (AU)/ml) antibodies
- Contraindication for frequent magnetic resonance imaging (MRI) (ie, pacemaker or other contraindicated implanted metal devices, or have claustrophobia that cannot be medically managed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized extended interval dosing of natalizumabAlso: EIDPersonalized extended interval dosing of natalizumab with a schedule from every 6 weeks, which will be further extended if the trough level exceeds 10 ug/ml. | Drug | Personalized extended interval dosing |
| Standard interval dosingAlso: SIDStandard interval dosing in control group and historic group | Drug | Historic cohort, Standard interval dosing |
Primary outcome
Change of T2 lesions on brain MRI
Time frame: Baseline, year 1, year 2
Assessing new/enlarging T2 lesions on brain MRI
13 secondary outcomes
Annualized relapse rate
Time frame: Baseline, year 1, year 2
Disability progression during follow-up
Time frame: Baseline, year 1, year 2
Cost analysis
Time frame: Baseline, year 1, year 2
JC virus conversion
Time frame: 6 monthly JCV measurement for two years
Course JC virus index
Time frame: 6 monthly JCV measurement for two years
Natalizumab wearing-off effect
Time frame: Baseline, year 1, year 2
Stability of natalizumab trough concentration
Time frame: 6 monthly natalizumab trough concentrations for two years
Patient preference
Time frame: Baseline
Quality of life: MSIS-29
Time frame: Baseline, year 1, year 2
Satisfaction of treatment: TSQM
Time frame: Baseline, year 1, year 2
Progressive multifocal leukoencephalopathy
Time frame: Trough study completion, an average of 2 years
Brain atrophy
Time frame: Baseline, year 1, year 2
Serum neurofilament light levels
Time frame: Trough study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Background: PubMed 35483387Foley JF, Defer G, Ryerson LZ, Cohen JA, Arnold DL, Butzkueven H, Cutter G, Giovannoni G, Killestein J, Wiendl H, Smirnakis K, Xiao S, Kong G, Kuhelj R, Campbell N; NOVA study investigators. Comparison of switching to 6-week dosing of natalizumab versus continuing with 4-week dosing in patients with relapsing-remitting multiple sclerosis (NOVA): a randomised, controlled, open-label, phase 3b trial. Lancet Neurol. 2022 Jul;21(7):608-619. doi: 10.1016/S1474-4422(22)00143-0. Epub 2022 Apr 25.
- Derived from this study: PubMed 37963723Toorop AA, van Lierop ZY, Gelissen LM, Hoitsma E, Zeinstra EM, van Rooij LC, van Munster CE, Vennegoor A, Mostert JP, Wokke BH, Kalkers NF, Hoogervorst EL, van Eijk JJ, Roosendaal CM, Kragt JJ, Eurelings M, van Genugten J, Nielsen J, Sinnige L, Kloosterziel ME, Arnoldus EP, van Dijk GW, Bouvy WH, Wessels MH, Boonkamp L, Strijbis EM, van Oosten BW, De Jong BA, Lissenberg-Witte BI, Barkhof F, Moraal B, Teunissen CE, Rispens T, Uitdehaag BM, Killestein J, van Kempen ZL. Prospective trial of natalizumab personalised extended interval dosing by therapeutic drug monitoring in relapsing-remitting multiple sclerosis (NEXT-MS). J Neurol Neurosurg Psychiatry. 2024 Apr 12;95(5):392-400. doi: 10.1136/jnnp-2023-332119.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Personalized extended interval dosing of natalizumab and Standard interval dosing in people with Relapsing Remitting Multiple Sclerosis, run by Amsterdam UMC, location VUmc at 24 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of T2 lesions on brain MRI (time frame: Baseline, year 1, year 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04225312, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.